Application of 3D–printed and patient-specific cast for the treatment of distal radius fractures: initial experience

Background Distal radius fracture is common in the general population. Fracture management includes a plaster cast, splint and synthetic material cast to immobilise the injured arm. Casting complications are common in those conventional casting technologies. 3D printing technology is a rapidly increasing application in rehabilitation. However, there is no clinical study investigating the application of a 3D–printed orthopaedic cast for the treatment of bone fractures. We have developed a patient-specific casting technology fabricated by 3D printing. This pioneering study aims to use 3D–printed casts we developed for the treatment of distal radius fractures, to provide the foundation for conducting additional clinical trials, and to perform clinical assessments. Method Ten patients with ages between 5 and 78 years are involved in the clinical trial. Patients are applied 3D–printed casts we developed. Orthopaedic surgeons carried out a six-week follow-up to examine clinical outcomes. Two questionnaires were developed for the assessment of clinical efficacy and patients’ satisfaction. These questionnaires are completed by physicians and participating patients. Results A 3D–printed cast creates a custom-fitted design to maintain the fractured bone alignment. No loss of reduction is found in all patients. Compartment syndrome and pressure sores are not present. Patient comfort gets positive scores on the questionnaire. All (100%) of the patients opt for the 3D–printed cast instead of the conventional plaster cast. Discussion A patient-specific, 3D–printed cast offers a proper fit to immobilise an injured arm and holds the fracture reduction appropriately. A custom-fitted structure reduces the risk of pressure-related complications due to the high and concentrated local stress. The ventilated and lightweight design minimises interference with a patient’s daily activities and reduces the risk of cutaneous complications. Patients express a strong preference for using a 3D–printed cast instead of a plaster cast. Limitations of the novel cast include a slight odour after heavy sweating and the relatively high cost due to the limitations of current 3D printing technologies. Conclusions This pioneering study is the first clinical trial on the application of a 3D–printed cast for the treatment of forearm fractures. The novel casting technology heals the fracture effectively without casting complications. The 3D–printed cast is patient-specific and ventilated as well as lightweight, and it features both increased patient comfort and satisfaction.

Application of 3D–printed and patient-specific cast for the treatment of distal radius fractures: initial experience

D Printing in Medicine
Application of 3D-printed and patient- specific cast for the treatment of distal radius fractures: initial experience
Yan-Jun Chen 0 2
Hui Lin 0 1
Xiaodong Zhang 4
Wenhua Huang 2
Lin Shi 1 3 6
Defeng Wang 1 5
0 Equal contributors
1 Research Center for Medical Image Computing, Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Prince of Wales Hospital , Shatin, NT , Hong Kong
2 Institute of Clinical Anatomy, School of Basic Medical Sciences, Southern Medical University , Guangzhou , China
3 Department of Medicine and Therapeutics, The Chinese University of Hong Kong , Shatin, NT , Hong Kong
4 Department Medical Radiology, The Third Affiliated Hospital of Southern Medical University , Guangzhou , China
5 Shenzhen Research Institute, The Chinese University of Hong Kong , Shenzhen , China
6 Chow Yuk Ho Center of Innovative Technology for Medicine, The Chinese University of Hong Kong , Shatin, NT , Hong Kong
Background: Distal radius fracture is common in the general population. Fracture management includes a plaster cast, splint and synthetic material cast to immobilise the injured arm. Casting complications are common in those conventional casting technologies. 3D printing technology is a rapidly increasing application in rehabilitation. However, there is no clinical study investigating the application of a 3D-printed orthopaedic cast for the treatment of bone fractures. We have developed a patient-specific casting technology fabricated by 3D printing. This pioneering study aims to use 3D-printed casts we developed for the treatment of distal radius fractures, to provide the foundation for conducting additional clinical trials, and to perform clinical assessments. Method: Ten patients with ages between 5 and 78 years are involved in the clinical trial. Patients are applied 3D-printed casts we developed. Orthopaedic surgeons carried out a six-week follow-up to examine clinical outcomes. Two questionnaires were developed for the assessment of clinical efficacy and patients' satisfaction. These questionnaires are completed by physicians and participating patients. Results: A 3D-printed cast creates a custom-fitted design to maintain the fractured bone alignment. No loss of reduction is found in all patients. Compartment syndrome and pressure sores are not present. Patient comfort gets positive scores on the questionnaire. All (100%) of the patients opt for the 3D-printed cast instead of the conventional plaster cast. Discussion: A patient-specific, 3D-printed cast offers a proper fit to immobilise an injured arm and holds the fracture reduction appropriately. A custom-fitted structure reduces the risk of pressure-related complications due to the high and concentrated local stress. The ventilated and lightweight design minimises interference with a patient's daily activities and reduces the risk of cutaneous complications. Patients express a strong preference for using a 3D-printed cast instead of a plaster cast. Limitations of the novel cast include a slight odour after heavy sweating and the relatively high cost due to the limitations of current 3D printing technologies. Conclusions: This pioneering study is the first clinical trial on the application of a 3D-printed cast for the treatment of forearm fractures. The novel casting technology heals the fracture effectively without casting complications. The 3D-printed cast is patient-specific and ventilated as well as lightweight, and it features both increased patient comfort and satisfaction.
3D printing; Patient-specific; Orthopaedic cast; Clinical trial; Assessments
Background
Distal radius fractures are common skeletal injuries and
occurred at all ages of the general population [
1, 2
]. These
types of fractures are reported as having one of the highest
incidences accounting for over 15% of bone fractures [
3, 4
].
Distal radius fracture management usually includes a plaster
cast, splint, and a moulded synthetic material cast to
immobilise the injured upper extremity [
5–9
]. A normal course of
the treatment includes the application of a cast and several
follow-up clinical visits lasting four to six weeks [
7, 10, 11
].
The traditional casts are described as having both poor
ventilation and an improper fit, while also causing discomfort.
These morbidities associated with conventional casts may
result in cast complications such as cutaneous diseases,
bone and joint injuries, or malunion [
7, 12, 13
]. The rate of
cast-related complications published is high with up to 31%
being reported in published studies [
14
].
The 3D printing technology is rapidly advancing in
medical applications [
15
]. In the manufacture of
rehabilitation tools, 3D printing technology is being applied to
orthopaedic cast fabrication to create patient-specific
features with an appropriate fit and a ventilated structure
[
16
]. Jake Evill and Deniz Karasahin proposed a novel design
of casts with a web-like structure and fabricated it by using
a 3D printing technique. The cast models were built from
3D–scanned images of subjects’ limbs and created by using
computer-aided design software, which can generate a
Stereolithography (STL) file, a standard file format widely
used for 3D printing. Kim et al. developed a hybrid model of
wrist orthosis composed of a 3D–printed frame and an
injection moulding shell [
16, 17
]. Although 3D printing has
made advances at a rapid pace in the development of casting
techniques, all published technologies for the design and
fabrication of 3D–printed casts are still in the concept stage
without clinical application [16]. To date, there is no clinical
study investigating the application of 3D–printed casts [
18
].
Our previous published study has developed a rapid
and intelligent technique to create a patient-specific
orthopaedic cast fabricated by 3D printing [
16
].
Orthopaedic surgeons with little knowledge of engineering can
design a high-quality cast in a short amount of time by
utilising the technique. The novel cast also has
additional features such as being ventilated and hygienic
advantages that potentially lower the risk of complications.
To our knowledge, there is no published clinical trial
using the 3D–printed cast for the treatment of distal
radius fractures. This study is to perform a pioneer clinical
trial for the casting technology utilising 3D–printed
casts for the treatment of distal radius fractures.
Methods
Ten patients (age range from 5 to 78 years old)
including four males and six females are involved in the
clinical trial. There were six patients who suffered distal
radius and ulnar styloid fractures. Distal radius fractures
were present in three patients. One patient sustained
fractures of both the distal radius and ulna. Exclusion
criteria included pathological/open fractures, fractures
requiring internal fixation and patients who were not
available for local follow-up. All clinical trials were
performed in southern China where the weather was humid
and warm, normally above 30 degrees Celsius during the
clinical testing period. Patients first underwent closed
reduction using traditional plaster cast fixation due to
tissue swelling. The first treatment stage lasted for one
week after swelling subsided. 3D–printed orthopaedic
casts developed by our published techniques [
16
] were
applied to these patients after one week fixation. Two
follow-up examinations and investigations were
performed about the second and sixth week after the
application of the 3D–printed cast [
11, 19
].
Patients’ limb injury data are obtained from
computerised tomography (CT) scanning or magnetic
resonance imaging. An injured patient is first examined using
radiography to identify the fracture type and locate the
region of the injury. Physicians then perform the closed
reduction followed by plaster casting in the initial phase.
To obtain workable data for later cast design, both arms
are scanned by a CT imaging system (Aquillion CX 64,
Toshiba, Japan) or MR (Achieva 1.5 T, Philips) imaging
equipment. The 3D scanning system using a 3D scanner,
which was employed in our previous study [
16
], is not
utilised in the clinical trial due to the difficulty of the
scanning procedure. To use a 3D scanner, patients must
keep their arms at a position without movement for
several minutes. This procedure is difficult to conduct.
In China, the use of CT or MR imaging is recommended
for further diagnosis and treatment of the injury. Before
scanning, a technician makes marks on the patient’s arm
to indicate the scanning scope as shown in Fig. 1(a). The
technician helps the patient to bend his wrist at an angle
(Fig. 1 (b)), which is termed a casting angle, where the
casting arm keeps the wrist at the same angle during the
treatment period. The value of the casting angle is
determined by an orthopaedic surgeon according to the injury
details. The patient lies on the patient table of the
scanning system, and then raises and bends his wrist at the
casting angle (Fig. 1(c)). Both hands with symmetric
postures are scanned to obtain raw data (Fig. 1(d)). Data
from the other forearm without injury can be the
alternative due to the swelling of the injured forearm
during the initial inflammation stage.
To evaluate the clinical trial, we designed
questionnaires concerning clinical efficacy and patient
satisfaction [
6, 7, 20
]. Orthopaedic surgeons and patients
worked together to complete the questionnaire after
seven weeks of treatment. The design of these
questionnaires is based on the existing questionnaire used in the
Marks indicating
scanning scope
Casting angle
(a)
(b)
(c)
(d)
hospital performing the clinical test and published
studies [
7
]. Two questionnaires have been designed including
two groups of survey questions associated with
treatment-related issues and patient satisfaction
assessments [
7
]. The first group lists four survey questions
related to clinical effect based on expert opinions and
previous investigation carried by Chinese orthopaedic
surgeons (Table 1). Pressure sore is an important
assessment item that is a common complication caused by
traditional casting [
14
]. Other common complications,
such as the stability of immobilisation, the severity of
compromised blood flow, and pressure-related patient
discomfort, are also included in the assessment. The first
questionnaire is completed by the surgeon who exams
patients at the second and sixth week after the
application of a cast. Patient satisfaction or patient sensation
and behaviour is another assessment including comfort,
patient compliance, preference between 3D–printed and
plaster cast, cast odour, and skin itchiness (Table 2). As
a pilot study, the assessment of the patients’ preference
addresses patients’ opinions about the physical structure
and wearer comfort. The inflammation-induced
uncomfortable experience, especially during the initial stage of
treatment, should be ruled out from the assessment.
With the assistance from doctors, patients complete the
second assessment questionnaire after the second and
seventh weeks of casting. Doctors only explain the
details of the questionnaire to let the patient fully
understand questions without any personal recommendations
to affect selection.
Patients’ raw models are input into the intelligent system
developed by our previously published study to perform
patient-specific design as per clinical requirements [
16
].
Short arm casts are designed for the treatment of distal
radius fractures. A cast model is designed as a holed
surface pattern with a flare on the lower edge near the
elbow for the consideration of ventilation and
wearerfriendly features (Fig. 2).
Medically compatible materials such as polypropylene
(PP) and polyamide (PA2200) are employed in the 3D
printing fabrication of an orthopaedic cast. These
materials are China Food and Drug Administration (CFDA)
approved as Class I materials for rehabilitation devices.
We utilise selective laser sintering (SLS) 3D printer EOS
P395 (Germany) or Stereolithography (SLA) printer
RS4500 (UnionTech, China) to produce the cast.
Technically, post-processing for a 3D–printed cast is
necessary for producing a final physical model. It
includes padding a 3D–printed cast, mechanical
grinding or rolling sharp edges, and adding fixation
components. As shown in Fig. 3, fixation straps are mounted
on the cast to adjust the assembly and create a cast that
Good terminal circulation
with a florid complexion
Venous obstruction relief after Pale skin, low Significant ischaemia of involved
physical movement or arm lifting temperature of the arm limb, compartment syndrome
Poor-0
Bad experience
wearing cast
Accepted reluctantly
Insisted on using
conventional cast
Stinky cast
Severely itchy
is tailor-fitted to an injured limb. In particular, cushion
pads are glued on some specific anatomical regions, such
as the wrist and ulnar styloid process, to avoid local high
pressure and scratching of the skin.
Results
A personalised and 3D–printed cast is fabricated as a
split structure with two half parts but still keeps the
circumferential structure when applied to an injured
extremity. A short arm cast extends from the
midforearm to the distal, proximal crease [
8
] (Fig. 4). In
some mild cases with slight injuries of a forearm, a short
arm cast can extend from the mid-forearm to the middle
area between the wrist and distal crease (Fig. 4).
All patients prefer the custom-fit feature that
establishes comfortable contact on the injured arm. The
surrounding Velcro straps allow the adjustment of the
assembly of the cast to accommodate the swelling
forearm in the initial inflammatory phase of a fracture
(Fig. 5). The 3D–printed cast satisfies the orthopaedic
requirement for the treatment of a fracture in terms of
the seven-week follow-up. The novel cast maintains
fracture bone alignment and immobilises the forearm
Holed surface
of a cast
Flare edge
during the healing process. No loss of reduction is found
in all participating patients. Moreover, no breakage
occurred in any cast during the treatment period.
Pressure sores, common casting complications
occurring in a traditional cast, were not present in any patients.
However, one female patient (age 56, height 5′1″, weight
41 kg) had a blister with around 5 mm diameter on the
bony prominence near the head of the ulna (Fig. 6). The
patient adjusted the cast by herself without consulting
with a physician. It then gave rise to a tight fit. No pain
and no complaints were reported from the patient. The
blister has disappeared one day after a physician adjusted
the cast. A skinny arm can be easily bruised from the cast
with relatively tight contact. This complication, skin
breakdown, was not present in any patients even though
thin patients were involved in the clinical trial.
Patients were taught how to check for compartment
syndrome by themselves within one week of the application
of the 3D–printed cast. As one of the most serious
complications of traditional casting techniques, compartment
syndrome was not found in any of the patients examined in
the second and sixth week after casting. Orthopaedic
surgeons inspected the skin appearance under the cast, and
no visual signs of pressure damage were found in these
patients. Complications associated with compromised blood
flow commonly occurring when using circumferential casts
and splints were not present during the healing period.
The first group of assessment (Table 1), clinical efficacy,
was scored as 9.8 out of 12 and 30% of patients scored this
group lower than 9 of the score. The lowest score was 8
out of 12 in the first group evaluation (Table 3). The
second group of the assessment (Table 2), patient
satisfaction to the application of the novel cast, was scored as
11.5 out of 15 (Table 3). In this questionnaire, 80% percent
of patients scored the new casting technique over 11 out
of 15, and no patients scored fewer than 8. Both
assessments of patient comfort and comparison between a
plaster and a 3D–printed cast were assigned full marks.
However, patient compliance was assigned as 2.1 out of 3
where the lowest score was rated.
Cast
Fixation strap
padding
Discussion
An appropriate casting technique not only holds the
fracture reduction at a proper anatomic position but also
minimises the risks of complications related to distal
fracture. Complications including cutaneous diseases,
compartment syndrome and vascular comprise, have
been reported in conventional cast application due to
the unbalanced pressures and high stiffness [
3, 12
].
Traditional casting creating mould utilising plaster and
thermoplastic has rigid structure without flexibility and
poor ventilation. In addition, the swelling of soft tissue
occurring in an injured forearm at the initial stage makes
it difficult to create patient-specific features. 3D–printed
casts are featured as patient-specific and fully ventilated
as well as lightweight structures [16]. 3D–printing
technology is an image-based technology combined with
rapid prototyping that can create a patient-specific cast
in terms of injury regions and severity. An orthopaedic
surgeon performs the closed reduction for a displaced
fracture followed by casting fixation. Patient-specific
features of casting play an important role to maintain the
alignment and avoid loss of closed reduction. Moreover,
the custom-fit structure ensures the matching surface
geometry between the cast and arm and thus disperses
pressure. The ventilated structure featured in the novel
cast confers the benefits of improved patient comfort
and reduced risk of cutaneous complications.
Acquisition of a patient’s image is an important
process for performing cast design. In the imaging
process, fracture patients are required to hold a special
posture to keep the forearm or lower leg in a natural
position. Participants with fractures have swollen arms
Middle between
wrist and distal
crease
Middle
forearm
Distal or
proximal
crease
where the original shapes are difficult to be discerned. This
study proposes the mirror technique, which scans the
counterpart of an injured limb. Eight out of 10 testing casts
used the contralateral arm. Bilateral symmetry exists in
natural biological structures. For example, surgeons assume
the bilateral symmetry of the human skeletal system for
surgery purposes. Also, Islam et al. demonstrated the
symmetric morphology of some human bones [
21
]. Thus,
the mirror technique offers relatively accurate patient data
and minimises imaging difficulties for the patient.
All patients participating in these clinical trials have
completed the entire therapeutic course without negative
Blister
clinical consequences. Rather, the patients in these trials
had superior clinical outcomes (Fig. 7). No clinical trial
using 3D–printed cast has been reported. The 3D–printed
cast offers custom-fitted immobilisation during the entire
treatment process. A cast with a correct fit can apply
appropriate orthopaedic pressure on the injured arm to
maintain bone alignment even after significant deformities
occurred in the soft tissue. No patients found the loss of
reduction in these clinical trials due to the technique that
ensured they were fitted correctly.
Pressure-related complications are reported with
traditional casts, especially circular casts. The cast utilised
for this study are designed as splitting and circular
structures with padding components, which can split the cast
to accommodate the injured limb and relieve pressure.
Slightly slow circulation is found after two weeks of cast
application due to the wearing pressure. Participated
patients can relieve the symptom through raising the
injured arms. Slight pain is developed from wearing
pressure, but no complaint is reported from patients.
Wearing pressures are necessary for any casting or splint
technology to maintain the reduction of the fracture and
perform orthopaedic corrections effectively [
22
].
Patientspecific and 3D–printed casts develop proper fit by the
shape of the injured arm and thus reduce the risk of
stress concentration since large contact areas are
created. Concentrated stress is considered as an important
factor associated with compartment syndrome. These
technical advantages are present in the clinical trial so
that no cases have compartment syndrome.
Both clinicians and patients are highly concerned about
pressure sores developing beneath the cast. To a patient
with a distal radius or Colles’ fracture, pressure sores
frequently develop in some regions of a forearm, such as on
the heads of the radius or ulna, due to their protruding
shapes. High local stresses generated from wearing
pressure occur in such regions. In the early two weeks of cast
application, pink but not broken skin arises on the regions
of heads of the radius or ulna accounting for 20% of
participating patients using a 3D–printed cast without a
padding layer. In addition, even though custom-fit features
are created, a slight motion between the injured arm
surface and the cast is common regardless of the type of
the cast application. The pink skin on those regions
results from high local pressure and motion-related
scratch. Two approaches to improve design have been
proposed in the 3D–printed cast: creating bump shape on
those regions and padding the regions as shown in Fig. 8.
Eight out of 10 patients were applied those improved
casts. Moreover, the material of cast with high stiffness
potentially developed a discomfort contact to the skin.
Those two improvements potentially reduce the risk of
high local pressure and gain clinical benefits to solve
pressure-related skin problems. The improvements bring
sound clinical outcomes that no reddened or pink skin
arises from the casting arm.
As a novel cast patients and clinicians never used, a
3D–printed cast gets high credit from patients with its
ventilated, comfortable and fashionable design. All
patients assign the highest score on the assessment of
comfort. The patient-specific structure creates moderate
contact like a fitted sleeve covering the injured arm and
prevents injuries from external impacts and scratches.
The ventilated structure keeps the microenvironment
dry between the skin and the cast and reduces the risk
Projecting area of
headof ulna
A improved design
creating a bump shape
of cutaneous complications. It should be noted that the
lightweight structure still maintains a high level of
strength. Engineering analysis performed in our previous
study demonstrated that the structure of the printed cast
was able to resist either normally imposed loads or
accidentally impact loads [
16
]. In this study, breakage due to
poor strength of the structure was not found in any of
the cases. The wearer-friendly design minimises the
interference with daily activities of the patient. Patient
compliance or treatment adherence is a challenge for a
physician to carry out this research. The details of
treatment technologies and potential side effects were
informed by the physician. In the early stage of the
clinical trial, most patients who show curiosity rather
than suspicion on the application of the 3D–printed cast
were mostly attracted by the novel 3D printing
technology with non-interventional treatment. A few patients
were sceptical since no such technology had been used
in clinical applications. After two weeks of application of the
novel cast, 100% of patients opted to utilise a 3D–printed
cast instead of a plaster cast (Fig. 9).
Fig. 9 The cumbersome structure of a conventional plaster cast
compared with a 3D–printed cast. Patients express a strong
preference to utilise a 3D printed cast instead of a conventional cast
There are some limitations of this study concerning
casting technology and clinical testing. First, acquisition
of a patient’s data is a challenge for a patient with a
fracture. A patient is asked to keep a required position
during scanning for the purpose of data integrity.
Additionally, we use mirror technology to acquire the
counterpart of the fractured arm. Variation between
arms is shown in the normal anatomy. Further
investigations should be required to evaluate the bilateral
symmetry of human bones digitally. There is no complaint
about the fitting issue by using the mirror technique.
The availability of biocompatible materials for 3D printing
fabrication is limited. We used polypropylene (PP) and
polyamide (PA2200) with Young’s modulus 1300Mpa. As
our experiences, a material with stiffness higher than
2000Mpa of Young’s modulus, like acrylonitrile butadiene
styrene (ABS), may cause uncomfortable contact to the
skin. In addition, although a ventilated structure has been
created, physicians receive a few of complaints about the
smelly cast from participating patients who sweat a lot in
hot weather. It should be noted that all clinical trials were
carried out in a southern Chinese city with hot and humid
weather during the testing period. The fabrication cost of
a 3D printing cast is relatively high, about $150 US
Dollars, compared with conventional alternatives less than
$50 US Dollars. The rapid growth of 3D printing
technologies would reduce the fabrication cost in the near
future. As a pilot study, we are mainly concerned with the
clinical feasibility of the application of the 3D–printed
cast. Due to the limited amount of patients, the initial
study investigated a small-sized group without performing
statistical analysis for comparison among conventional
and 3D–printed casts.
As a new casting technology, we conducted the clinical
trials with the focus on mild distal fracture. Cast design
and 3D–printing fabrication would require a longer
time. In emergency situations requiring a cast for the
case of an acute fracture, as per our initial experiences,
the 3D–printed cast would not be suggested currently.
Its personalised structure and ventilated as well as
lightweight design bring about quality patient experiences as
confirmed by positive assessments of patient comfort
and acceptance. Those two assessments would be helpful
for the improvement of the current casting technology.
This pilot study provides an initial experience on how to
apply the 3D printing technique in the treatment of
fractures. The future study would perform clinical trials on a
larger scale sample size, and as a comparison study
among conventional and 3D–printed casts to assess
whether clinical differences were statistically significant.
Conclusions
This study performs a pilot study with the focus on the
clinical trial for the treatment of distal radius fracture
using patient-specific and 3D printing cast developed by
our published techniques. The novel cast performs
circumferential support for the fractured forearm and
prevents the injury from external impact. The
patientspecific design maintains the alignment of fracture bones
and creates the custom-fit and moderate wearing
pressure to avoid compartment syndrome and pressure
sores, which is considered as the casting complication to
challenge conventional casting technology. The
ventilated structure and fashionable design of the novel cast
combined with the 3D printing fabrication increase
patient comfort and satisfaction. Superior clinical
outcomes have been obtained from clinical trials.
Acknowledgements
The authors wish to acknowledge Diya Ma, Matthew-Lun Wong, Ka-Long Ko,
Ka-Hei Ko and Jin-Peng Lee for their important contributions to the software
development.
Funding
The work described in this paper was supported by a grant from the
Research Grants Council of the Hong Kong Special Administrative Region,
China (Project No.: CUHK 14113214), grants from the Innovation and
Technology Commission (Project No: ITS/149/14FP, GHP/028/14SZ, ITS/293/
14FP), grants from CUHK Technology and Business Development Fund
(Project No.: TBF16MED002, TBF16MED004), a grant from The Science,
Technology and Innovation Commission of Shenzhen Municipality (Project
No.: CXZZ20140606164105361), and a grant from The Scientific Research
Project of Guangdong Province (Project No.: 2014B090901055).
Authors’ contributions
YC performed the clinical trial, designed the questionnaires and edited the
manuscript. HL conceived the cast design, carried out the clinical trial, and
both drafted and edited the manuscript. LS carried out data collection and
analysis. XZ carried out data collection and provided clinical advice. WH
conducted the clinical trial and critically revised the manuscript. DW carried
out the method design and development and critically revised the
manuscript. All authors read and approved the final manuscript.
Ethics approval and consent to participate
The study concerning the client’s right to privacy. The study was approved
by the Ethical Committee of The Third Affiliated Hospital of Southern
Medical University (reference number: 201,603,006) and was conducted
according to the principles of the Declaration of Helsinki. The experimental
methods used in the study were in accordance with medical practice, and
the subjects were protected.
Competing interests
The authors declare that they have no competing interests.
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
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